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Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis

NCT04335617 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-11-03

No results posted yet for this study

Summary

national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings

Conditions

  • Proctitis Radiation

Interventions

DRUG

MMPF (Micronized purified Flavonoid-Fraction)

500mg film-coated tablet, oral route, tablets should be taken at meal times. 4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily, one at midday and one in the evening

OTHER

Placebo

4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily

Sponsors & Collaborators

  • Servier Affaires Médicales

    collaborator INDUSTRY

  • Medical University Innsbruck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2023-02-26
Completion
2023-08-26

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335617 on ClinicalTrials.gov